Study of Treatment Used for Migraine Headaches (MK-0974-076) (MASTER)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01421277
First received: July 28, 2011
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

This study will describe the reasons for triptan utilization patterns (continuation and discontinuation) in triptan-naïve participants and assess the stability of treatment utilization patterns over time according to standard medical guidelines or clinical practice standards of the investigating physician.


Condition
Migraine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Migraine Attack Study of Treatment, Efficacy and Resource Use (MASTER) - McKesson Substudy (MK-0974-076)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants on triptan therapy study entry [ Time Frame: At entry on study ] [ Designated as safety issue: No ]
  • Number of participants on triptan therapy at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Enrollment: 161
Study Start Date: May 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Participants with migraine
Participants being treated by their Physicians for migraine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants with physician-diagnosed migraine (with or without aura) who have had at least two, but not more than 8 moderate to severe migraines during the 30 days prior to screening. Participants must have received a triptan prescription 3 months (± 2 weeks) prior to being identified by the physician, must have been triptan-naïve prior to that initial prescription, and must have taken triptan medication at least once within 6 months prior to the date of informed consent for screening.

Criteria

Inclusion criteria:

  • At least 18 years of age in the United States at the time of consent
  • Physician-diagnosed migraine with or without aura
  • At least two and up to a maximum of 8 moderate to severe migraine attacks during the 30 days prior to screening
  • Initial triptan prescription 3 months (± 2 weeks) prior to being identified as eligible for this study, and triptan-naïve before that initial prescription
  • Used triptan medication at least once within 6 months prior to the date of informed consent for screening
  • Internet access and able to complete online surveys via electronic data entry

Exclusion criteria:

  • Treated with triptans prior to this study
  • In active litigation and compensation issues including disability dispute cases with a Government agency
  • Participation in a clinical trial within the last 90 days
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01421277     History of Changes
Other Study ID Numbers: MK-0974-076
Study First Received: July 28, 2011
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 22, 2014